A trend that began 40 years ago is now entering a new or second wave as pharmaceutical companies shift their focus from cost savings to knowledge wealth. Outsourcing is integral to pharmaceutical operations, as companies have sought to reduce costs and enhance flexibility. Over time, sponsor companies gain access to specialized domain expertise in key geographic regions and local knowledge in countries where they often don’t have presence.

The first phase of pharmaceutical outsourcing was largely in response to the ballooning costs of drug development as well as the complexities that came with large-scale mergers and acquisitions (M&As). In the interim, companies have outsourced more and more business processes, often to offshore organizations in an effort to manage the cost constraints of keeping products on global markets.

However, with increasingly complex and varied regulatory requirements and trends, there is a need for a more nuanced approach to outsourcing, where expertise and regulatory intelligence are combined with efficiency and cost containment. At the same time, pharmaceutical companies have needed to find innovative ways to strengthen their pipelines and develop more efficient methods to support the product lifecycle, while remaining compliant. This has led to the next frontier in outsourcing: the management of established, marketed products, supported by a tailored, blended model of in-country, near-shore, and offshore resources with proven expertise and a commitment to innovation.

Stephan Hütter is associate director, Global Program Management at PharmaLex.

When referring to this article, please cite it as S. Hütter, “The Next Frontier in Pharmaceutical Outsourcing,” 

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